Necker Hospital
Paris, 75015, France
NCT Number: NCT03520855
The aim of this study is to evaluate the contribution of a serious game in the reinforcement of knowledge acquired during therapeutic education of type 1 diabetes paediatric patients.
This evaluation will take place within 3 months of the diagnosis.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Paris, 75015, France
Type 1 diabetes gather multiple metabolic pathologies secondary to a deficiency in insulin secretion or insulin action, characterized by chronic hyperglycaemia. Diagnosis is based on fasting glycaemia above 1.26 g/l or above 2 g/l any time of the day.
Currently, it is recommend initial therapeutic education additionally to insulin therapy, in the type 1 diabetes care. Initial therapeutic education's role is to develop 3 specific skills : self-care skills, safety skills and adaptation skills. This approach gives to the patient the abilities to monitor himself, to handle emergency situations and to modify his lifestyle to treat his disease correctly.
In the serious game, the patient will directly evolve in a virtual environment, with places reflecting his real life such as paediatric diabetology centre, hospital, home, school. He will have to complete quests with his own virtual avatar, that reflect situations his disease can confront him to. Each quest ends with a questionnaire.
The principal objective of this research is to evaluation the contribution of a serious game (DIVE) in the reinforcement of knowledge acquired during therapeutic education of type 1 diabetes paediatric patients.
This research is designed in two arms, gathering 100 patients, each arm has 50 patients. Both arms benefit initial therapeutic education, except the experimental group which is added a serious game .
To measure the impact of the serious game,investigators will compare HbA1c dosage between groups (with HPLC technique), 3 months after diagnosis; but also the number of hypo or hyperglycaemia in the month before M3 final consultation. They will also evaluate self-care skills and safety skills with role-plays at the end of hospitalisation and 3 months later. Technical gestures will also be evaluated by referent nurses.
Evaluation of the patient's well-being will take place with two types of questionnaire, WHO-Five and DOQLY during M3 final consultation.
This research will bring essential information on the development of video games in other paediatric chronic diseases, as a first step in the development of the use of video games in therapeutic care of type 1 diabetes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
DIVE software will be accessible via internet, children and parents will have to their disposition a room at the hospital specifically to work on the software. The DIVE software is organized in chapters, each matches an item of the therapeutic education process and ends with a knowledge assessment. The child has to end every chapter and succeed every evaluation to pursue on the next chapter. Measures will be taken in order to avoid contamination bias between groups. Children will have to connect to DIVE 2 times per week for a time duration of at last 1 hour.
Initial therapeutic education only will be applied in this group, with the help of doctors and nurses, based on theoretical educational lessons, reported on the AJD book.
Health education sessions will also be taught by nurses.
Time frame: 3 months
50 questions (disease, treatment, food,…)
Time frame: 3 months
Glycemia follow-up with a self-monitoring book in each arm
Time frame: 3 months
Statement of the number of hypo or hyperglycaemia within the months preceding the consultation
Time frame: 3 months
Evaluation of self-care skills with role-plays and assessment of feelings of competence from their DT1 (scorecard, Barrow chart )
Time frame: 3 months
Evaluation of patient's well-being with auto-questionnaires
Time frame: 3 months
Evaluation of patient's well-being with auto-questionnaires
Assistance Publique - Hôpitaux de Paris
Other
Contribution of a Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
Acronym: eDIVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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